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Does the Negativation of the Glucose Hydrogen Breath Test Come Along With a Reduction of the Symptoms of Gaz Incontinence ?

Primary Purpose

Anal Incontinence

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Metronidazole
CArbosylane
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anal Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Gaz incontinence for more than 3 months
  • Afflilied to national health security
  • Having read and sign the information letter and consent form

Exclusion Criteria:

  • Pregnancy
  • use of antibiotics, probiotics, IPP for less tha n 3 months
  • past of small intestinal bacterial overgrowth
  • ischemic, inflammatory colitis,colo-rectal cancer
  • diabetes
  • allergy to metronidazole
  • psychiatric disease
  • patients who do not speak or read french

Sites / Locations

  • Physiology Unit, Hopital Charles Nicolle, 1 rue de Germont

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Metronidazole

Carbosylane

Arm Description

3 intakes per day during 10 days

3 intakes per daysduring 10 days

Outcomes

Primary Outcome Measures

number of gaz incontinence episodes

Secondary Outcome Measures

Full Information

First Posted
January 11, 2011
Last Updated
June 2, 2015
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT01275560
Brief Title
Does the Negativation of the Glucose Hydrogen Breath Test Come Along With a Reduction of the Symptoms of Gaz Incontinence ?
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objectives of this work are: 1/to estimate the frequency of a positive glucose breath test in favour of a small intestinal bacterial overgrowth in a population of patients consulting for gaz incontinence by comparison to a population of control subjects; 2/to estimate versus a conventional treatment the efficiency of an antibiotic treatment; in case of small intestinal bacterial overgrowth diagnosed by the glucose breath test, to improve gaz incontinence

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metronidazole
Arm Type
Experimental
Arm Description
3 intakes per day during 10 days
Arm Title
Carbosylane
Arm Type
Active Comparator
Arm Description
3 intakes per daysduring 10 days
Intervention Type
Drug
Intervention Name(s)
Metronidazole
Intervention Description
Metronidazole,per os,500mg, 3 per day during 10 days
Intervention Type
Drug
Intervention Name(s)
CArbosylane
Primary Outcome Measure Information:
Title
number of gaz incontinence episodes
Time Frame
3 days before randomization and treatement and 3 days after 10 days of treatment (antibiotic or conventionnal treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Gaz incontinence for more than 3 months Afflilied to national health security Having read and sign the information letter and consent form Exclusion Criteria: Pregnancy use of antibiotics, probiotics, IPP for less tha n 3 months past of small intestinal bacterial overgrowth ischemic, inflammatory colitis,colo-rectal cancer diabetes allergy to metronidazole psychiatric disease patients who do not speak or read french
Facility Information:
Facility Name
Physiology Unit, Hopital Charles Nicolle, 1 rue de Germont
City
Rouen
ZIP/Postal Code
76031
Country
France

12. IPD Sharing Statement

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Does the Negativation of the Glucose Hydrogen Breath Test Come Along With a Reduction of the Symptoms of Gaz Incontinence ?

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